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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM
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IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM Back to Search Results
Catalog Number 0064599
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 an immucor technical support used a remote electronic connection method to transfer camera images, event logs and result batches for the issue described.No instrument problem was identified.No sample or reagents were returned to immucor for investigation.The immucor internal record number for this report is (b)(4).
 
Event or Problem Description
On (b)(6) 2018 a customer reported that they received unexpected negative reactions with capture-r ready-screen 3 on the galileo neo instrument.
 
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Brand Name
GALILEO NEO
Common Device Name
AUTOMATED BLOOD BANK SYSTEM
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key8258062
Report Number1034569-2019-00026
Device Sequence Number19313628
Product Code KSZ
UDI-Device Identifier10888234001041
UDI-Public10888234001041
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
BK100033
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number0064599
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/27/2018
Initial Report FDA Received Date01/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age68 YR
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